BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVERGE POROUS SHELL

    MDR report key: 2780652 · Received October 5, 2012

    Report

    Report Number
    1822565-2012-02017
    Event Type
    Injury
    Date Received
    October 5, 2012
    Report Date
    September 6, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. IN GENERAL, PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD¿L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN, AND ONE LEG IS LONGER THAN THE OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVERGE POROUS SHELL LPH ZIMMER, INC. 1650034-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CANCELLOUS BONE SCREW: CAT# 430107015| EPSILON DURASUL INSERT: CAT # 437728057| LOT# 1633545| LOT # 1598441| APR II FEMORAL STEM: CAT # 741701135| LOT # UNK